510(k) K090017
- Device
- CARTO 3 EP NAVIGATION SYSTEM, V1.0 AND ACCESSORIES
- Applicant
- BIOSENSE WEBSTER, INC.
- 510(k) number
- K090017
- Product code
- DQK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-10-13
- Date received
- 2009-01-02
- Regulation
- 870.1425
- Classification name
- Computer, Diagnostic, Programmable
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Balaka Das
- Address
- 3333 Diamond Canyon Rd. Diamond Bar CA US 91765 91765
FDA Registration Numbers#
- 3032109181
- 3012811961
- 3012528160
- 3012154226
- 3009831876
- 3009443693
- 3000126629
- 3006082230
- 3016406615
- 9673241
- 3013581838
- 3007137685
- 3006087789
- 3018940143
- 2183715
- 9617277
- 9610816
- 3000279201
- 3007208829
- 3012552532
- 1000122786
- 3008203003
- 1000165971
- 3005210579
- 1224919
- 3032916632
- 3007184699
- 3045498928
- 9616760
- 1320894
- 3013943846
- 3017840980
- 3013679558
- 2133641
- 3002672225
- 3009600098
- 3021769057
- 3017845286
- 3008452825
- 3037724692
- 3001592626
- 8030978
- 3000976525
- 3008012314
- 2135338
- 1218950
- 3007029079
- 3009254201
- 1058584
- 8022257
- 2184149
- 3016678045
- 9615102
- 3018783526
- 3016674095
- 1058031
- 3008329188
- 3033558564
- 2183926
- 3042175841
- 9610105
- 2134265
- 2183744
- 3013627970
- 3012268816
- 3010728615
- 2133810
- 3009715978
- 9710602
- 3003144120
- 3014272734
- 3013300026
- 3004594159
- 3003616071
- 3015151147
- 2031044
- 3004415095
- 3008159616
- 3017401510
- 3004016520
Source Documents#
Other 510(k) Records For Product Code DQK #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253692 | AVVIGO™+ Multi-Modality Guidance System | Boston Scientific | 2026-08-21 |
| K262005 | Affera Integrated Mapping System | Medtronic, Inc. | 2026-08-21 |
| K253576 | CorVista System® with PCWP Add-On | Analytics For Life, Inc. | 2026-07-26 |
| K262006 | EnSite™ X EP System | Abbott Medical | 2026-07-15 |
| K252978 | ScioCardio ECG Analysis Platform | Synergen Technology Labs, LLC | 2026-07-09 |
| K253463 | ILR ECG Analyzer (IM007) | Implicity, Inc. | 2026-07-02 |
| K261119 | NorthStar Mapping System (MAP01 or MAP01-01) | Imricor Medical Systems, Inc. | 2026-06-30 |
| K253088 | OneStim-DUO Cardiac Stimulator (MP5003-4CO) | Micropace Pty, Ltd. | 2026-06-12 |
| K261329 | Intra-Operative Positioning System (IOPS) (MC-1);IOPS Viewpoint Simple Curve Catheter, 75cm (C00751);IOPS Viewpoint Simple Curve Catheter, 125cm (C01251);IOPS Viewpoint Double Curve Catheter, 75cm (C00752);IOPS Viewpoint Double Curve Catheter, 125cm (C02152);IOPS Guidewire 2 (ATW-2);IOPS Fiducial Tracking Pad (T02111);IOPS Guidewire Handle (H01035) | Centerline Biomedical | 2026-06-10 |
| K252859 | ZEUS Platform (FG0501US) | iRhythm Technologies, Inc. | 2026-05-29 |
| K260212 | EnSite™ X EP System | ABBOTT MEDICAL | 2026-04-20 |
| K253861 | ACORYS MAPPING SYSTEM | Corify Care S.L | 2026-04-13 |
| K253473 | Synchrony | Stereotaxis, Inc. | 2026-04-01 |
| K253186 | HemoSphere Nano Monitor (HSNANO1) | Edwards Lifesciences, LLC | 2026-02-24 |
| K252972 | CARTO™ 3 EP Navigation System V8.4 | Biosense Webster, Inc. | 2026-02-20 |
Legacy Summary#
summary
FDA Review#
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